RecruitingNot Applicable

TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

Germany100 participantsStarted 2024-10-22

Plain-language summary

The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment? 2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics? 3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria \- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR). Exclusion Criteria * Any access route other than transfemoral. * Valve-in-valve procedures. * History of prior bioprosthetic valve implantation. * Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system. * Diagnosis of liver cirrhosis. * Esophageal disorders, including but not limited to esophageal varices. * Thrombocytopenia or coagulation disorders. * Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of a commissural alignment

Timeframe: Day 1

Presence of symmetrical position

Timeframe: Day 1

Transvalvular gradients

Timeframe: baseline + day 1

Effective orifice area (EOA)

Timeframe: baseline + day 1

Doppler velocity index

Timeframe: baseline + day 1

Paravalvular leakage

Timeframe: Day 1

Turbulent flow

Timeframe: baseline + day 1

Pressure recovery

Timeframe: Day 1

Trial details

NCT IDNCT06896227

SponsorHeinrich-Heine University, Duesseldorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

Tobias Zeus, Prof

0211 81 18800 zeus@med.uni-duesseldorf.de

View on ClinicalTrials.gov More Transcatheter Aortic Valve Replacement trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Presence of a commissural alignment

Timeframe: Day 1

Presence of symmetrical position

Timeframe: Day 1

Transvalvular gradients

Timeframe: baseline + day 1

Effective orifice area (EOA)

Timeframe: baseline + day 1

Doppler velocity index

Timeframe: baseline + day 1

Paravalvular leakage

Timeframe: Day 1

Turbulent flow

Timeframe: baseline + day 1

Pressure recovery

Timeframe: Day 1